Atlas FDA

ENCORE REVERSE SHOULDER PROSTHESIS

FDA 510(k) clearance K041066 · decided 2005-03-24

Clearance details

K-number
K041066
Device name
ENCORE REVERSE SHOULDER PROSTHESIS
Applicant
Encore Medical L.P.
Decision
Substantially Equivalent
Date received
2004-04-23
Decision date
2005-03-24
Days to decision
335 days
Clearance type
Traditional
Product code
PHX
Device class
2
Regulation number
888.3660
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
InSet Reverse Total Shoulder System (K254128)Shoulder Innovations, Inc.2026-04-13
Blueprint Patient-Specific Instrumentation (K253674)Stryker Corporation (Tornier, S.A.S.)2026-04-03
INHANCE™ Reverse Shoulder System (K253624)Depuy Ireland UC2026-03-11
MSS - Monobloc stem (K250644)Medacta International S.A.2026-02-03
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Recalls involving this device

RecordFirmDate
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-1 recall (Z-0098-2024)Encore Medical, LP2023-10-12
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Inser recall (Z-0184-2008)Encore Medical, Lp2007-12-19
Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Inser recall (Z-0185-2008)Encore Medical, Lp2007-12-19
Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, recall (Z-1566-05)Encore Medical, Lp2005-09-21